Class II

Medical Device Recall: Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only

Cordis US Corp · March 4, 2025

Reason for Recall

product mix-up; Vascular stent labeled as one size but contains a different size.

Distribution

US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: Japan

States Affected

AR, AZ, FL, NJ, TN

Quantity Affected

1 unit

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1511-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.